Ratcheting inserter device and suture anchor arrangement

ABSTRACT

A ratcheting inserter device for tensioning a knotless suture anchor includes an outer inserter shaft and an inner inserter shaft having a common longitudinal axis. A ratcheting mechanism provided between the inner inserter shaft and the outer inserter permits rotation of the inner inserter shaft in one direction relative to the outer inserter shaft. The outer inserter shaft has a protrusion at a distal end that is received by an anchor outer sleeve of a suture anchor to prevent relative rotation thereof, and the inner inserter shaft has a projection at the distal end that is received by an inner core of the anchor for rotational movement therewith. The ratcheting inserter device rotates the inner core of the suture anchor to spool and tension suture thread. Thereafter, the ratcheting mechanism is disengaged and the inner inserter shaft is forced axially into the anchor outer sleeve.

FIELD OF THE INVENTION

The invention relates to a ratcheting inserter device and a sutureanchor arrangement for securing a suture anchor to bone and adjustingthe tension of knotless suture thread.

BACKGROUND OF THE INVENTION

During some injuries, soft tissue, such as tendons or ligaments, cantear away from hard tissue, such as bone. Accordingly, it becomesnecessary to reattach the soft tissue to the bone in order to facilitatethe healing process. Various types of devices are used to reattachtissue, such as screws, staples and suture anchors. The instantinvention relates to this latter type of attachment device.

Suture anchors may be inserted into a preformed hole made in hardtissue, while other anchors are self-tapping. The anchors typicallyinclude an eyelet through which lengths of repair suture or workingsuture are threaded, which working suture is inserted simultaneouslywith the anchor into the hard tissue. In this regard, an inserter deviceor driver may be utilized in conjunction with the anchor to install ordrive same into hard tissue and may carry such working sutures thereon.For the purpose of providing pull-out resistance, some anchors areexteriorly threaded, while others are ribbed or barbed to provideappropriate pull-out resistance.

U.S. Patent Publication No. 2010/0063542 A1 discloses a knotless sutureanchor for soft tissue repair. The suture anchor includes an outertubular anchor member having raised teeth spaced thereabout on the innersurface thereof, an inner tubular anchor member having a pointed tip atthe distal end thereof and pawls on an outer surface of the inner anchormember that are part of a ratcheting arrangement that enables rotationof the inner anchor member in one direction with respect to the outeranchor member. In this manner, a suture secured to the anchor can berotated in the one direction to collect suture thread onto a spoolportion of the inner anchor member and to tension the suture thread forplacing a tendon or other tissue into contact with a bone.

U.S. Patent Publication No. 2010/0121348 A1 discloses an insertion toolfor rotating an inner tubular anchor member having a pawl with respectto an outer tubular anchor member of a suture anchor. The inner tubularanchor member of the suture anchor includes a square drive socketopening at a proximal end for receiving an inner shaft of the insertiontool. The insertion tool is provided with an outer shaft surrounding theinner shaft and an outer shaft handle for maintaining the position ofthe outer shaft in engagement with the outer tubular anchor member ofthe suture anchor. An inner shaft handle is engaged with the inner shaftfor rotating the inner tubular anchor member of the suture anchor withrespect to the outer anchor member. The distal end of the hollow outershaft includes a flange for insertion within a slot or aperture in theouter tubular anchor member of the suture anchor and the inner shaft hasa square shape or other keyed arrangement for engaging the socket of theinner anchor member of the suture anchor. In operation, the insertiontool rotates the inner anchor member of the suture anchor in thedirection permitted by the pawls of the inner anchor member whilemaintaining the outer anchor member in a fixed position to enablespooling of suture thread and adjustment of the tension thereof. Theopposite ends of the sutures are secured to a tendon or other tissuedirectly or via a second suture anchor and the sutures are tensioned sothe tendon or other tissue properly contacts the bone.

SUMMARY OF THE INVENTION

According to the invention, in some embodiments a ratcheting inserterdevice includes an outer shaft handle secured to an outer insertershaft, and an inner shaft control secured to an inner inserter shaftthat typically extends within the hollow outer inserter shaft to thedistal end thereof. Further, the ratcheting inserter device includes aspacer disposed between the outer shaft handle and the inner shaftcontrol. A ratcheting mechanism is formed by pawls which projectinwardly from an inner surface of the outer inserter shaft and teethwhich project outwardly from an outer circumferential surface of theinner inserter shaft. The ratcheting mechanism prevents rotation of theinner shaft control and thus the inner inserter shaft in one direction.Thus, a suture anchor utilized with the ratcheting inserter device isgreatly improved as the invention enables rotation and spooling ofsuture thread within the suture anchor for tensioning, while limitingthe number of movable parts within the suture anchor.

The invention also enables securement of the suture anchor aftertensioning of the suture thread by a final screw fit step. In thisarrangement, an inner shaft control has a screw shaft that projectstoward the suture anchor. The screw shaft is surrounded by the spacer,which is disposed between the outer shaft handle and the inner shaftcontrol. Upon removing the spacer and applying a force on the innershaft control toward a suture anchor, the inner inserter shaft moveaxially relative to the outer inserter shaft while the threaded shaft ofthe inner shaft control contacts a corresponding female threaded portionof the outer shaft handle permitting rotation thereof. Rotation of theinner shaft control rotates the inner inserter shaft, whichsimultaneously moves axially toward the suture anchor in order to driveand rotate threads at a proximal end of the anchor inner core of thesuture anchor into corresponding female threads provided on an innersurface of a bore hole of the anchor outer sleeve to move the anchorinner core into the anchor outer sleeve to ensure that the suture anchoris secured to bone and to maintain the tension on the suture threads. Inone embodiment, the axial movement of the inner inserter shaft relativeto the outer inserter shaft causes the teeth of the inner inserter shaftto disengage from the pawls of the outer inserter shaft, allowing forthe spooled suture to be rotated in a direction opposite that which isallowed by the ratcheting inserter mechanism. In such an embodiment,tension applied to the spooled suture can urge rotation in a directionthat serves to further tighten the threaded engagement of the inner coreand the outer sleeve of the anchor.

The invention also provides a simplified press fit arrangement whereinafter the suture threads are tensioned by the ratchet inserter device,the spacer is removed. Then, the inner shaft control, which does nothave screw threads on the projecting shaft, is pushed toward the sutureanchor and the distal end of the inner inserter shaft press fits ananchor inner core into an anchor outer sleeve of a suture anchor.

In another embodiment wherein the suture anchor is a self-tappinganchor, the object of the invention is to provide a ratcheting mechanismwith the inserter device, whereby the suture anchor maintains itsposition in the bone and the tension of suture threads is adjustedwithout a spacer provided with the inserter device and without a finaldriving step for forcing an anchor inner core into an anchor outersleeve. Instead the inner core is initially mounted entirely within theouter sleeve.

The invention also permits axial movement of the inner inserter shaftrelative to the outer inserter shaft so that the ratchet mechanismformed by the shafts disengages to permit rotation of the inner shaftcontrol in either direction to move an anchor inner core relative to ananchor outer sleeve of the suture anchor for enabling the release oftension for suture thread connected to the suture anchor.

One possible use of the arrangement according to the invention is inarthroscopic shoulder surgery, wherein the dislocation of soft tissuerelative to the bone is a fairly common injury. However, thisarrangement may also be utilized for the repair of small joints, such asthe elbow, wrist, ankle, hand or foot. The arrangement may additionallybe used to reattach small ligaments in the knee, and may even be used inbladder-neck suspension surgery.

Other objects and purposes of the invention will be apparent to personsfamiliar with arrangements of this general type upon reading thefollowing specification and inspecting the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a ratcheting inserter device and asuture anchor arrangement.

FIG. 2 is a partial view of the ratcheting inserter device with thespacer removed.

FIG. 3 is a perspective view of the ratcheting inserter device and thesuture anchor with a portion of the outer inserter shaft removed.

FIG. 4 is a perspective view of an inner inserter shaft.

FIG. 5 is a side view of the outer inserter shaft.

FIG. 6 is an end view of the outer inserter shaft.

FIG. 7 is a cross-sectional view of the inner and outer inserter shaftstaken generally along VII-VII in FIG. 3.

FIG. 8 is a perspective view of a removable spacer.

FIG. 9 is a perspective view of an anchor outer sleeve of a sutureanchor.

FIG. 10 is a side view of the anchor outer sleeve.

FIG. 11 is a perspective view of an anchor tip of a suture anchor.

FIG. 12 is a perspective view of an anchor inner core of a sutureanchor.

FIG. 13 is a side view of the anchor inner core.

FIG. 14 is a side view of a screw fit suture anchor before a finalinsertion step.

FIG. 15 is a partial longitudinal-sectional view of the inserter shaftsof a portion of the ratcheting inserter device.

FIG. 16 is a perspective view of a press fit suture anchor prior to apress fit step.

FIG. 17 is another perspective view of the suture anchor of FIG. 16.

FIG. 18 is a partial view of the distal end of a ratcheting inserterdevice with the spacer thereon.

FIG. 19 is a partial view of the distal end of the ratcheting inserterdevice of FIG. 19, after the spacer has been removed and the innerinserter shaft moved toward a suture anchor.

Certain terminology will be used in the following description forconvenience in reference only, and will not be limiting. For example,the words “upwardly”, “downwardly”, “rightwardly” and “leftwardly” willrefer to directions in the drawings to which reference is made. Thewords “inwardly” and “outwardly” will refer to directions toward andaway from, respectively, the geometric center and designated partsthereof. The word “distally” will refer to the direction towards the endof the arrangement located closest to the patient, and the word“proximally” will refer to the direction towards the end of thearrangement located remote from the patient. Said terminology willinclude the words specifically mentioned, derivatives thereof, and wordsof similar import.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a suture anchor and inserter arrangement 20 for implantinga suture anchor 22 into a bone and for tensioning knotless suturethreads connected thereto. The suture anchor 22 is disposed at a distalend of a ratcheting inserter device 24. The ratcheting inserter device24 includes a hollow tubular outer inserter shaft 26 having a distal end28 that receives the suture anchor 22 and a proximal end 30. At theproximal end 30, the outer inserter shaft 26 is secured to an outershaft handle 32. The outer shaft handle 32 includes a plurality ofrecesses 34 to facilitate gripping, and a longitudinally oriented openinner bore hole along longitudinal axis 35. The inserter device 24 alsoincludes a spacer 36 separating the outer shaft handle 32 from an innershaft control 38, such as an inner shaft knob, disposed at the proximalend thereof.

FIG. 2 shows the outer shaft handle 32 and the inner shaft control 38 ofthe inserter device 24 with the spacer 36 removed. The inner shaftcontrol 38 includes a left-threaded projecting screw shaft 39 that isreceivable by female threads formed in an inner surface of the bore holeof the outer shaft handle 32. The spacer 36 prevents the projectingscrew shaft 39 from being threaded into the corresponding threads of theouter shaft handle 32.

FIG. 3 shows a different perspective view of the suture anchor andinserter arrangement 20 that includes an inner inserter shaft 40 that issecured at a proximal end to the inner shaft control 38 and extendsthrough the outer shaft handle 32 and substantially the entire length ofthe outer inserter shaft 26 when the inner shaft control is in contactwith the spacer 36 as shown in FIG. 1. Further, the inner inserter shaft40 includes outwardly projecting teeth 42 as shown in the view of FIG.3, with the outer inserter shaft 26 removed near the proximal end 30.

FIG. 4 shows a reduced diameter area 44 of the inner inserter shaft 40that includes the teeth 42 which extend radially outwardly and arespaced circumferentially about a section of the inner inserter shaft 40.FIG. 4 shows additional details of the inner inserter shaft 40,including a flat two sided flange 46 at a proximal end for insertioninto a slot or bore formed at the distal end of the projecting screwshaft 39 of the inner shaft control 38. Further, the inner insertershaft 40 includes a projection 48 at the distal end for insertion intothe suture anchor 22. In some embodiments, the projection 48 has asquare or hexagonal shape, or other keyed shape.

FIG. 5 shows a side view of the outer inserter shaft 26 which at theproximal end 30 is secured to the distal end of the outer shaft handle32 in a fixed manner. At the distal end 28, a protrusion 50, such as aflange, extends outwardly from the distal end for insertion into acorresponding receiver of the suture anchor 22. Further, a pair ofdepressions 52 are formed in the outer surface of the outer insertershaft 26. The end view of the outer inserter shaft 26 shown in FIG. 6illustrates the ratchet mechanism 54 formed by a pair of pawls 56disposed on an inner surface of the outer inserter shaft 26. The pawls56 are formed in part when the depressions 52 are created on the outersurface of the outer inserter shaft 26. The pawls 56 arecircumferentially spaced from the longitudinal axis and at the sameaxial location within the outer inserter shaft 26.

As shown in FIG. 7, two teeth 42 of the six teeth shown for the innerinserter shaft 40 are in contact with the pawls 56 of the outer insertershaft 26. The pawls 56 limit rotation of the inner inserter shaft 40 toone direction.

The teeth 42 are circumferentially spaced about a section of the innerinserter shaft 40 and oriented radially outwardly. In some embodiments,the teeth 42 are circumferentially spaced on the outer surface of theinner inserter shaft 40 at intervals of about 30°, about 45°, or about60° as shown in FIG. 7. The pawls 56 of the ratchet mechanism 54 arespaced circumferentially about an inner surface of the outer insertershaft 26 at about 180° from each other. Other embodiments includeadditional pawls or a single pawl. In one embodiment, the teeth 42 andthe pawls 56 are formed of a metal along with the entirety of the outerinserter shaft 26 and the inner inserter shaft 40. Further, in otherembodiments the pawls 56 are formed on the outer surface of the innershaft 40 and the teeth 44 are formed on the inner surface of the outershaft 26. The inserter shafts 26, 40, the elongate outer shaft handle34, and the projecting screw shaft 39 all share a common longitudinalaxis when assembled. The suture anchor 22 discussed below shares thesame common longitudinal axis as the ratcheting inserter device 24during insertion into bone and tensioning of suture threads.

The spacer 36 as shown in FIG. 8 has an opening 60 and flexible legs 62for receiving the projecting screw shaft 39 of the inner shaft control38. Further, the spacer 36 has a tab 64 for ease in removal from thescrew shaft 39 of the inner shaft control 38 by applying a forceradially and outwardly from the longitudinal axis 35 of the inserterdevice 24.

Screw Fit Suture Anchor

The screw fit suture anchor 22 shown in FIGS. 1 and 3 includes threecomponents. The first component is an elongate outer sleeve 80 as shownin FIG. 9. The outer sleeve 80 includes a top member 82 at the proximalend having an eyelet 84, an open bore hole 86 and an inner threadedregion 88 extending about the inner surface of the bore hole at the edgeat the proximal end. A protrusion receiving aperture 89 is provided atthe proximal end of the top member 82 adjacent the inner threaded region88. The suture anchor 22 also includes frusto-conical elements 90defining the outer surface along the length thereof. The frusto-conicalelements 90 are shaped similarly to the elements disclosed for sutureanchors and discussed in U.S. Patent Publication 2010/0121348 publishedMay 13, 2010, the disclosure of which is hereby incorporated byreference in its entirety. The frusto-conical elements 90 are alsosimilar to the elements disclosed in U.S. Patent Publication2010/0063542 published Mar. 11, 2010, the disclosure of which is herebyincorporated by reference in its entirety.

The outer sleeve 80 includes elongate apertures 92 for receiving suturethread therein and paths along the outer surface thereof for guidingsuture thread, for example through the eyelet 84, to or from the sutureanchor 22. FIG. 10 shows an opposite side of the anchor outer sleeve 80and includes a second elongate aperture 96 that typically is essentiallysymmetrical to the first aperture 92. Thus, the aperture 96 shown inFIG. 10 is initially in alignment with the aperture 92 to provide atransverse path relative to the longitudinal axis 98 for suture threadsto extend through the body of the outer sleeve 80. The presence of theenlongate apertures 92 further serve as reliefs that allow for theanchor outer sleeve 80 to expand as suture is spooled on the anchorinner core 110 as described in more detail below.

The second component of the suture anchor is an anchor tip 100 having atip end 102 and an anchor tip shaft 104 as shown in FIG. 11. The tip end102 is for contacting and driving into bone to implant the suture anchor22.

The third component of the suture anchor 22 is an anchor inner core 110as shown in FIG. 12. The anchor inner core 110 has an open inner corebore hole or socket 112. At the proximal end 114 of the inner core 110,the inner core bore hole 112 in the illustrated embodiment has ahexagonal shape for receiving the hexagon shaped projection 48 disposedat the distal end of the inner inserter shaft 40. As discussed above,other shapes are contemplated. At the distal end 116 of the anchor innercore 110, a rounded inner core bore hole (not shown) is shaped toreceive and retain the anchor tip shaft 104 of the anchor tip 100. Inanother embodiment, the anchor outer sleeve 80 has an opening at thedistal end shaped to receive the anchor tip shaft 104.

As shown in FIG. 12, at the outer edge at the proximal end 114 of theinner core 110, radially projecting core threads 118 with dimensionsthat correspond to the inner threaded region 88 of the outer sleeve 80are provided. The anchor inner core 110 also includes an aperture 120extending along a path transverse to the longitudinal axis 121 of theinner core and through the entirety of the inner core to provide a pathfor suture thread therethrough. With reference to FIG. 13, the anchorinner core 110 includes a tapered indented outer face area 122 axiallyaligned with the aperture 120 for enabling placement of a suture threadtherethrough. Thereafter, winding of suture thread occurs duringrotation of the anchor inner core 110 relative to the outer sleeve 80.

The assembled screw fit suture anchor 22 is shown in FIG. 14 and has anouter sleeve 80, an inner core 110 located therein and an anchor tip 100at the distal end thereof. The suture anchor 22 is shown in apreliminary state before a final step of inserting the anchor inner core110 further into the anchor outer sleeve 80 has been performed.

In some embodiments, the anchor outer sleeve 80 is formed from PEEK(polyether-etherketone) material. The anchor inner core 110 can beformed of a carbon fiber reinforced PEEK material, which providesgreater hardness than the PEEK material of the anchor outer sleeve 80.

Operation

To implant a knotless suture anchor 22, the ratcheting inserter device24 shown in FIG. 1 is utilized as follows.

The suture anchor 22 is secured to the protrusion 50 of the outer shaft26 of the inserter device 24. The protrusion 50 projects into theprotrusion receiving aperture 89 at the top member 82 of the outersleeve 80. Thus, the outer sleeve 80 is incapable of rotation relativeto the outer inserter shaft 26. Likewise, the projection 48 of the innerinserter shaft 40 is received in the socket 112 of the anchor inner core110. Thus, the anchor inner core 110 is rotatable in combination withthe inner inserter shaft 40.

The start-up position for the ratcheting inserter device 24 is shown inFIG. 15. The teeth 42 provided in the reduced diameter area 44 of theinner inserter shaft 40 are circumferentially spaced and projectoutwardly to engage with a pawl 56 of the outer inserter shaft 26 thatis disposed radially adjacent to the teeth 42 projecting outwardly fromthe inner inserter shaft 40. The pawl 56 is oriented to preventleft-handed or counterclockwise rotation of the inner inserter shaft 40when viewed from the outer shaft handle 32 or inner shaft control 38 andtoward the suture anchor 22. In the FIG. 15 arrangement, the spacer 36maintains the relative axial positions of the teeth 42 and pawls 56 thatform the ratchet mechanism 54.

In a first operating step, the ratcheting inserter device 24 has forceapplied at the proximal end to drive the suture anchor 22 into bone, andpreferably until the eyelet 84 of the outer sleeve 80 is disposed at orflush with the surface of the bone.

After the step of forcing the suture anchor 22 into bone tissue, theinner shaft control 38 is rotated in a clockwise direction. As thespacer 36 is provided between the inner shaft control 38 and the outershaft handle 32, the projecting screw 39 of the inner shaft control 38does not approach or contact the distal end of the outer shaft handle 32and the axial positions of the shafts 26, 40 and other elements do notchange. Rotation of the inner shaft control 38 rotates the innerinserter shaft 40, which causes rotation of the anchor inner core 110via the projection 48 at the distal end of the inner inserter shaft,which is disposed in the socket 112. Suture threads that are disposed inthe suture anchor 22 are threaded through the elongate apertures 92, 96of the outer sleeve 80 and through the radially oriented aperture 120 ofthe anchor inner core 110. The suture threads are wound up or spooledabout the outer face area 122 of the anchor inner core 110 shown in FIG.14 by the rotation of the anchor inner core 110 relative to the anchorouter sleeve 80. The spooling of suture threads about the anchor innercore 110 causes portions of threads disposed away from the suture anchor22 and bone to be drawn into the suture anchor 22, such as through theeyelet 84, to increase tension of the suture threads, which typicallyare connected to a tendon or other tissue that is intended to contact asurface of the bone. The spooling of the suture threads also createspressure between the suture threads and the anchor outer sleeve 80 whichmay serve to compress the suture threads and expand the anchor outersleeve 80 thereby increasing fixation strength.

The tensioning is maintained by the teeth 42 of the inner inserter shaft40 at the ratchet engaged area 130 shown in FIG. 15, as the teeth are inradial alignment with the ratchet pawls 56 of the outer inserter shaft26.

In a next operating step, the spacer 36 is removed from the ratchetinginserter device 24. Force is applied at the proximal end of the innershaft control 38, thus moving the projecting screw shaft 39 toward thesuture anchor and into engagement with the corresponding female threadswithin the bore hole of the outer shaft handle 32. During the movementof the inner shaft control 38, the threads of the projecting screw shaft39 align with the female threads of the outer shaft handle bore hole.The inner inserter shaft 40 also moves toward the suture anchor 22,whereby the reduced diameter area 44 advances to the ratchet disengagedarea 132 relative to the outer inserter shaft 26 as shown in FIG. 15. Inthis position, the inner shaft control 38 can be rotated in eitherdirection. Then the control 38 is turned in a left handed orcounterclockwise direction when viewed from the control and toward thesuture anchor 22, and the threads of the projecting screw shaft 39advance inwardly as the inner shaft control 38 is typically turned aone-half rotation or less about the longitudinal axis thereof.Simultaneously, the left-handed rotation of the inner inserter shaft 40causes rotation of the anchor inner core 110. The male core threads 118of the anchor inner core 110 shown in FIGS. 12-14 are received by thecorresponding sized female inner threaded region 88 of the outer sleeve80. Thus, the turning of the inner shaft control 38 rotatably andaxially moves the control screw shaft 39 into the outer shaft handle 32,while the anchor inner core 110 is simultaneously rotatably and axiallymoved into the anchor outer sleeve 80. The effect of this last step isto better secure the suture anchor 22 to bone and to enhance the fit ofthe anchor inner core 110 with the anchor outer sleeve 80 to preventloss of tension of the suture thread that is spooled about the innercore 110 of the suture anchor 22. In this arrangement, the thread sizesare essentially the same for each of the elements. When the step iscompleted, the proximal ends of the anchor outer sleeve 80 and theanchor inner core 110 typically provide a flat face at the proximal end,except for the socket 112 and the protrusion receiving aperture 89. Inan additional embodiment of the invention, at the ratchet disengagedarea 132, reversed pawls (not shown) are formed in a similar manner tothe pawls 56 of the outer inserter shaft 40 to form a left-handedratcheting mechanism thereat. Thus, a surgeon would be prevented frominadvertently turning the inner shaft control 38 in a right handdirection that would further tension the suture thread, and the user islimited to performing a left-hand turn to move the inner core 110 intothe outer sleeve 80 of the anchor 22 as discussed above.

In another embodiment of the invention, the inner shaft control 38 canbe pulled away from the inserter device 24 to move the reduced diameterarea 44 and teeth 42 of the inner inserter shaft 40 into the ratchetdisengaged area 134 shown in FIG. 15. The projection 48 must havesufficient length and the inner core bore hole 112 must have sufficientdepth to remain engaged. In the disengaged area 134, the inner shaftcontrol 38 can be rotated in a left hand direction to reduce tension andunspool suture thread. Thereafter, the inner shaft control 38 can bemoved axially toward the inserter device 24 to reengage the ratchetmechanism 54 when the reduced diameter area 44 of the inner insertershaft 40 is provided in the ratchet engaged area 130. The spacer 36 actsas a stop to prevent the teeth 42 from moving beyond the ratchet engagedarea 130 and into the ratchet disengaged area 132 shown in FIG. 15.

In operating the inserter device 24, left hand turning of the innershaft control 38 in order to screw the anchor inner core 110 into theouter sleeve 80 has such a small amount of rotation that the effect onthe tension of suture threads is minimal. In one embodiment, a rotationof about one-quarter to about one-half turn for the inner shaft control38 is desired.

As to various suture thread arrangements and the winding of suturethread, such winding is detailed in the '348 patent publication, whichpreviously has been incorporated by reference herein, wherein thewinding increases the diameter of the wound thread on an inner tubularmember until the suture thread contacts an inner wall of an outertubular member.

Press Fit Suture Anchor

FIGS. 16-19 illustrate another embodiment of the invention similar tothe above discussed embodiments. The FIG. 16 suture anchor arrangementrequires a final axial impact step to press fit the anchor inner coreinto the anchor outer sleeve, instead of the screw fit embodimentdiscussed above. The suture anchor 200 shown in FIG. 16 includes ananchor outer sleeve 204 having frusto-conical elements 206, a top member208 at a proximal end and elongate apertures 210 on each side thereof.The apertures 210 provide a transverse path relative to the longitudinalaxis 212 for passing suture thread through the outer sleeve 204.Further, an anchor tip 214 is provided at the distal end of the outersleeve 204.

The suture anchor 200 includes an anchor inner core 220 having a sidewall 222 extending thereabout and an inner core aperture 224 providedtherein. As in the earlier embodiment, the apertures 210, 224 areinitially registered with one another to enable the passing of an end ofa suture thread through the entirety of the suture anchor 200. After asuture thread is passed through the apertures 210, 224, rotation of theanchor inner core 220 spools thread circumferentially about the sidewall222 of the inner core.

FIG. 17 is another perspective view of the suture anchor 200. Thisarrangement shows a protrusion receiving aperture 226 that receives thecorresponding protrusion 50 of the outer inserter shaft 26 of theratcheting inserter device 24. Further, a socket 230 is provided forreceiving the projection 48 of the inner inserter shaft 50 of theratcheting inserter device 24.

To perform the driving operation, the ratcheting inserter device 24 ismodified to remove the screw threads from the projecting screw shaft 39,which enables linear movement of the inner shaft control 38 along thelongitudinal axis of the inserter device 24 after the spacer 36 isremoved. Another alteration to the ratcheting inserter device 24 isprovided at the distal end of the inner inserter shaft 26. Morespecifically, FIGS. 18 and 19 show the distal end 28 of the outerinserter shaft 26 and the inner inserter shaft 40 in two positions. Theprotrusion 50 of the outer inserter shaft 26 is received by theprotrusion receiving aperture 226 shown in FIG. 17, to secure the outerinserter shaft 40 to the suture anchor 200.

In addition to the protrusion 50 of the outer inserter shaft 26 beinglocated in the protrusion receiving aperture 226 of the suture anchor,the projection 48 of the inner inserter shaft 40 is disposed in theinner core bore hole 230 of the inner core 220. Thus, as in the earlierembodiment, the ratcheting mechanism 54 enables rotation of theprojection 48 in one direction whereby the anchor inner core 230 spoolsthe suture thread that extends through the apertures 210, 224 of thesuture anchor 200 to adjust the tension of the suture thread. Therefore,the anchor 200 functions in essentially the same manner as the abovedescribed screw fit anchor, except for the final step, wherein the innercore 220 is driven into the anchor outer sleeve 204.

Upon proper tensioning of the suture thread, the anchor inner core 220shown in FIG. 17 is press fit into the anchor outer sleeve 204 so as tobe substantially flush with the top end of the anchor as follows. Thespacer 36 is removed and the inner shaft control 38 is pushed axially sothat the inner inserter shaft 40 moves toward the suture anchor 200. Asthe inner inserter shaft 40 moves axially, a drive block structure 234disposed at the distal end of the inner inserter shaft 40 contacts theproximal end of the anchor inner core 220 and drives the inner coreinwardly to a position (not shown) wherein the proximal end thereof isessentially flush with the proximal end of the anchor outer sleeve 204.In driving and securing the anchor inner core 220 into the anchor outersleeve 204, the fin-shaped portions at the proximal end of the innercore are capable of cutting the outer sleeve 204 during the insertionthereof. In this arrangement, the anchor inner core 220 can be a carbonfiber reinforced PEEK material and the anchor outer sleeve can be asofter PEEK material that enables the cutting type of action. In otherembodiments, various materials having appropriate properties arecontemplated for the anchor inner core and the anchor outer sleeve. Inyet another embodiment the anchor outer sleeve 204 has grooves (notshown) that mate with the fin-shaped portions at the proximal end of theinner core and prevent rotation.

In another embodiment, wherein self-tapping anchors are utilized, thefinal step of screwing the inner core into the outer sleeve of thesuture anchor 22 may not be necessary. Since the suture anchor (notshown) is designed as an integrated element that is initiallyself-tapped into the bone with no further fitting occurring, the anchorinner core is initially seated completely within the outer sleeve sothat the proximal ends are flush with each other. Thus, the use of aspacer for the inserter device 24 is unnecessary and movement of theinner inserter shaft 40 along the longitudinal axis thereof isunnecessary. The anchor inner core 220 is fitted within the anchor outersleeve to permit rotation relative to the outer sleeve when a largerotating force is applied thereto. The ratcheting inserter device 24rotatably tensions the suture thread. The spooled thread that is wrappedabout the outer face area of the anchor inner core 110 contacts an innerwall of the anchor outer sleeve 80, whereby friction develops thatassists in resisting rotation of the inner core 110 relative to theouter sleeve 80. Therefore, unwinding of the spooled suture thread isprevented without a driving step for the anchor inner core 110. Further,the wound thread applies a radially outwardly oriented force to theinner wall of the anchor outer sleeve to enhance the engagement of thesuture anchor to surrounding bone.

Although particular embodiments have been disclosed in detail forillustrative purposes, it will be recognized that variations ormodifications of the disclosed apparatus, including the rearrangement ofparts, lie within the scope of the present invention.

What is claimed is:
 1. A ratcheting inserter device, comprising: ahollow outer inserter shaft having a distal end and a proximal end,including an outer shaft handle disposed at the proximal end and aprotrusion projecting from the outer shaft distal end; an inner insertershaft having a distal end and a proximal end, including an inner shaftcontrol at the proximal end and a projection at the inner shaft distalend; and a ratcheting mechanism permitting rotation of the innerinserter shaft in one direction relative to the outer inserter shaft andpreventing rotation of the inner inserter shaft in the opposingdirection relative to the outer inserter shaft, wherein at least aportion of the inner shaft is positioned within the outer inserter shaftand the inner inserter shaft is rotatable relative to the outer insertershaft in the one direction.
 2. The ratcheting inserter device of claim1, wherein the ratcheting mechanism comprises at least one pawl formedin one of an outer surface of the inner inserter shaft and an innersurface of the outer inserter shaft.
 3. The ratcheting inserter deviceof claim 2, wherein the ratcheting mechanism further comprises teethformed in the other of the outer surface of the inner inserter shaft andthe inner surface of the outer inserter shaft for engaging the at leastone pawl to prevent rotation of the inner inserter shaft in the onedirection.
 4. The ratcheting inserter device of claim 3, wherein theteeth and the at least one pawl are aligned radially toward each otheralong a portion of the respective inner inserter shaft and the outerinserter shaft.
 5. The ratcheting inserter device of claim 1, whereinthe protrusion comprises a flange and the inner shaft control comprisesan inner shaft knob.
 6. The ratcheting inserter device of claim 1,including a spacer disposed between the outer shaft handle and the innershaft control.
 7. The ratcheting inserter device of claim 6, wherein theinserter device is configured so that removal of the spacer enablesforce applied to the inner shaft control toward a distal end of theinserter device, to axially move the distal end of the inner insertershaft outwardly beyond the distal end of the outer inserter shaft fordriving an anchor inner core of a suture anchor into an anchor outersleeve of the suture anchor.
 8. The ratcheting inserter device of claim7, wherein the inner shaft control includes a projecting screw shaftoriented along a common longitudinal axis of the outer inserter shaftand the inner inserter shaft, and the outer shaft handle includes anopen bore with matching screw threads for receiving the projecting screwshaft, and wherein axial movement of the inner inserter shaft disengagesthe ratcheting mechanism, whereby the inner shaft control is capable ofrotating in an opposite direction to the one direction.
 9. Theratcheting inserter device of claim 8, wherein the anchor outer sleeveincludes an inner threaded region at a proximal end and the inner coreincludes core threads at the proximal end, and wherein during movementof the inner shaft control rotatably and axially into the outer shafthandle and toward the suture anchor, the distal end of the innerinserter shaft rotatably and axially drives the core threads of theinner core into the threaded region of the outer sleeve.
 10. Theratcheting inserter device of claim 9, wherein the inner shaft controlrotates in a range from about a one quarter rotation and about a threequarter rotation to axially advance a distance that corresponds to thewidth of the spacer.
 11. The ratcheting inserter device of claim 7,wherein the ratcheting mechanism comprises a first ratcheting mechanismand the axial movement of the inner inserter shaft disengages the firstratcheting mechanism, and wherein a second ratcheting mechanism axiallyspaced from the first ratcheting mechanism engages the inner insertershaft to limit rotation thereof.
 12. The ratcheting inserter device ofclaim 1, wherein the projection fits into a bore hole of an inner coreof a suture anchor and the projection is configured to rotate the innercore of the suture anchor for tensioning suture threads coacting withthe suture anchor.
 13. The ratcheting inserter device according to claim1, wherein the inner shaft control is movable axially away from theouter shaft handle to disengage the ratcheting mechanism and to enablerotation of the inner inserter shaft in each direction relative to theouter inserter shaft.
 14. A knotless suture anchor, comprising: ananchor inner core having a proximal end with an inner bore hole and anaperture oriented transversely to a longitudinal axis of the anchorinner core for receiving an end of a suture thread; an anchor outersleeve having an open bore hole at a proximal end for receiving theanchor inner core and including apertures oriented transversely to alongitudinal axis of the anchor outer sleeve for receiving an end of asuture thread, the anchor outer sleeve receiving and enclosing a firstportion of the anchor inner core, with a second portion at the proximalend of the anchor inner core extending away from the proximal end of theanchor outer sleeve; and an anchor tip, wherein the anchor inner core isrotatable relative to the anchor outer sleeve.
 15. The suture anchor ofclaim 14, wherein the anchor inner core includes core threads at theproximal end thereof, and wherein the anchor outer sleeve includes aninner threaded region in the open bore hole at the proximal end thereof.16. The suture anchor of claim 14, wherein the anchor inner core has afinned region at the proximal end thereof, and wherein the anchor innercore is capable of cutting the anchor outer sleeve during insertiontherein.
 17. A method for securing a suture anchor into a bonecomprising: providing a suture anchor comprising an anchor inner coreand an anchor outer sleeve having an open bore hole at a proximal endfor receiving and enclosing a first portion of the anchor inner corewith a second portion of the anchor inner core extending away from theproximal end of the anchor outer sleeve; driving the suture anchor intobone with an inserter device to dispose the proximal end of the anchorouter sleeve adjacent a bone surface; tensioning suture threads coactingwith the suture anchor; and driving the anchor inner core into theanchor outer sleeve.
 18. The method of claim 17, wherein the anchorinner core includes core threads at the proximal end thereof, andwherein the anchor outer sleeve includes an inner threaded region in theopen bore hole at the proximal end thereof, and the step of driving theanchor inner core into the anchor outer sleeve comprises simultaneouslyapplying an axial force and a rotating force, for rotating the anchorinner core into the anchor outer sleeve.
 19. The method of claim 17,wherein the inserter device comprises a ratcheting inserter device andthe step of tensioning suture threads comprises operating the ratchetinginserter device to rotate the anchor inner core relative to the anchorouter sleeve.
 20. The method of claim 17, including the step of moving aportion of an inserter device away from the suture anchor to releasetension of the suture threads.